SOURCE: PharmaPros

March 04, 2008 09:00 ET

MCRA, PharmaPros Announce Launch of Clinical Trial Reimbursement Solution

WASHINGTON, DC--(Marketwire - March 4, 2008) - Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), an independent orthopedic consulting firm focusing on regulatory, clinical, intellectual property and reimbursement strategy execution, and PharmaPros Corporation, a consulting services organization focused on innovation in clinical trials technology solutions, today announced a partnership in support of MCRA's unique Clinical Trial Reimbursement Solution (CTRS), a first-in-class combination of technology, and reimbursement and clinical trial experience.

The landscape of medical device reimbursement is changing rapidly. It is clear that the clinical data required for a successful regulatory approval does not necessarily encompass the clinical data needed for successful reimbursement of a product. It is also clear that the underlying reasons for this dynamic are the distinct requirements which need to be satisfied within the different constituencies. The common bond for bridging this gap is the design and collection of clinical data, which accounts for both regulatory and reimbursement considerations. As such the CTRS is designed to provide integrated strategic and administrative support during a clinical trial, with the collection of payment and claims information conducted in parallel with the collection of clinical data.

"We are excited about the partnership with MCRA. MCRA Reimbursement has been instrumental in defining the requirements for the reporting library, and through the use of our technology, in particular the site collaboration portal, MCRA has had impressive results not only in securing coverage, however through their focus on supporting the investigator sites, we have seen consistent improvements in performance at the sites over the course of a trial," said Peg Regan, CEO of PharmaPros.

The CTRS is broken down into five distinctive areas that provide real value to the customer: clinical trial support, coverage during the trial, current & future coding, real time reporting and post approval commercialization support. In combination with its expertise in regulatory and reimbursement strategies, MCRA will leverage PharmaPros proprietary workflow system, which includes extensive data tracking and reporting capabilities for parallel collection of data for reimbursement and regulatory submission. PharmaPros and MCRA have co-developed a rich report library, which can be configured to meet each client's unique requirements. During the trial, PharmaPros' data capture and reporting environment is used by MCRA advisors to monitor and direct reimbursement. Coding, coverage, and payment support for sites and investigator's billing staff are also an integrated part of the solution.

David Lown, General Manager of MCRA, said, "In today's environment orthopedic clinical trials are required to be comprehensive and rigorous for either the FDA or for the continuing medical education of surgeons. As such, clinical trials in the U.S. today are producing best in class data, but the costs associated are substantial. MCRA believes parallel data collection of reimbursement information is prudent and that these practices will be the standard within 5 years."

About MCRA

MCRA was founded in 2003 and provides "first-in-class" service to its clients through its superior knowledge base, global surgeon relationships and deeply experienced management team. The true value of MCRA is the integration of 5 business value creators -- regulatory, reimbursement, clinical, intellectual property and quality assurance. MCRA places particular emphasis on working with companies at all stages of development, whether they are single-product companies or companies with several thousand technologies.

About PharmaPros Corporation

PharmaPros is a consulting services organization committed to innovation in clinical trials solutions. Its team of industry veterans collaborates with clients to bridge the gap between clinical trials and clinical technology through its unique Electronic Data Lifecycle Management (eDLM) approach. A proven methodology incorporating a proprietary workflow system with extensive data integration, tracking and reporting capabilities, eDLM provides a comprehensive view into the completeness and accuracy of trial data, enabling time critical decision making throughout the lifecycle of a trial. Working with companies both large and small, PharmaPros has been delivering services to the Life Sciences industry since 1996. PharmaPros is privately funded corporation, with headquarters in Cambridge, MA. www.pharmapros.com

Contact Information

  • Media Contacts:
    David W. Lown
    MCRA
    Ph: (212) 583-0250 extension 2111

    Valerie Harding
    Ripple Effect Communications
    617-536-8887